A Randomization (Randomisation) Service for Multicenter Clinical Trials (original) (raw)

The Randomizer provides a self-serve, easy to use, secure and 24/7 randomization service (IWRS) for multicenter clinical trials.

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Easy to Use

The Randomizer is accessible anytime, anywhere and via any device that has a modern web browser and is connected to the Internet. Investigators randomize subjects with only a few clicks and are immediately notified of the treatment allocation. Trial coordinators can set up a new trial in minutes. They can add trial sites and users at any time during participant enrollment.

Comprehensive

Permuted blocks, minimization, biased coin, urn randomization, and other algorithms are available. Full support for open and double-blinded trials, a customizable role-based access control, email notifications and reporting functions are built in. For statisticians, the Randomizer provides a simulation tool which can be used to test a trial design or to generate randomization lists.

Secure & Validated

All transactions are logged, the trial's audit trail and the list of randomizations can be downloaded and analyzed at any time by authorized users. Network traffic between the web browser and the Randomizer is encrypted using TLS (Transport Layer Security) with strong encryption. The software's GCP-compliance has been confirmed by the Austrian Federal Office for Safety in Health Care (BASG).

Demo

The demo is a fully functional copy of the randomization software, except that randomization for clinical trials is limited to 10 subjects per trial. Randomization lists can be generated for up to 5000 subjects.

To access the demo, a one-time registration is required.

Visit the Demo

Pricing

Our pricing is based on the type of sponsor and the number of randomizations.

Randomization Lists

FREE

Trials with Academic Sponsors

€ 500.- per trial
(includes the first 50 randomizations)

Trials with Commercial Sponsors

€ 1000.- per trial
(includes the first 70 randomizations)

Special price scales for large trials (i.e. > 1000 randomizations) are available. Please contact us for a quote.

We provide registered users with access to our self-serve randomization service, subject to our Terms and Conditions. We will offer reasonable levels of continuing technical support to assist authorized users in the use of the service. Technical support is provided via email during normal business hours.

Additional services, particularly for statistical consultation, must be stipulated separately.

Our randomization service has been used successfully in hundreds of trials. However, early trial termination may occur in clinical trials due to many issues, e.g., problems with subject recruitment, etc. Therefore, if - within six months after trial activation - no more than 10 subjects have been randomized into a trial and the trial coordinator confirms trial termination, the full basic fee will be refunded.

Get Started

If you have checked out our demo and now want to get started using the Randomizer for your trial, just follow these steps:

  1. If this is the first time you are using the Randomizer for a trial, pleasecontact us. We will respond with the link to our production server and further instructions. Once you've registered on our production system, you can start setting up your trial immediately and randomize up to 10 subjects. The limit of 10 subjects will be removed after we have received your trial registration form (see below).
  2. Download the Trial Registration Form (also available in German) and ourTerms and Conditions (also available inGerman). Return the registration form - properly filled in and signed - as a scanned PDF via email tooffice@randomizer.at or contact us to get a link where you can securely upload the PDF. Please note that both the Trial Registration Form and the Terms and Conditions are in PDF format. You may need Adobe's free Adobe Reader to view these files.
  3. As soon as we have received the Trial Registration Form, we will remove the initial randomization limit from your trial.
  4. We will send you the first invoice after subject recruitment has been activated.

Publications of some of the trials that used the Randomizer

If you have any questions regarding our randomization service or just have a comment for us, we'd be pleased to hear from you. Send us an email (in English or German) to office@randomizer.at (for general inquiries) orsupport@randomizer.at (for technical support questions) or enter your message in the form below and click "Send Message" when you are done.

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